Kornimate/medical-research-clean huggingface dataset:
a study for pms of azl-m in the treatment of adult participants with essential hypertension in south korea

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the safety by determining the incidence rates of all adverse events (aes) including serious adverse events (saes)/serious adverse drug reactions (adrs), unexpected aes and adrs that are not reflected on the precaution in the use, adrs already known, non-serious adrs and other safety related information (laboratory values changes, etc).

this is a long-term prospective, observational post-marketing surveillance study of azilsartan medoxomil in participants with essential hypertension. this study will assess the safety and effectiveness of azilsartan medoxomil prescribed as a monotherapy or taken concomitantly with other anti-hypertension therapies in real-world clinical practice settings. the study will enroll approximately 3000 participants. the data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: * participants with essential hypertension the multi-center study will be conducted in south korea. data collection will be based on routinely scheduled and emergency visits over the surveillance period, scheduled at visit 1 (baseline), visit 2 (6 weeks), visit 3 (3 months or more less than 6 months) and visit 4 (6 months or more \[month 9\]). the overall duration of the study will be approximately 6 years. all participants will be followed up for 9 months after drug administration.

Eligibility criteria:
inclusion criteria: 1. with essential hypertension. * newly diagnosed with essential hypertension or who have no long-term history of hypertension medication after diagnosis (the participant has a sbp or dbp \>=140 or 90 mmhg, respectively). * receiving treatment with other hypertension medications. 2. newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies. exclusion criteria: 1. treated with azilsartan medoxomil outside of the locally approved label in south korea. 2. with known hypersensitivity or presence of any contraindication to azilsartan medoxomil. 3. use of aliskiren in combination with azilsartan medoxomil in participants with diabetes or with moderate to severe renal impairment (glomerular filtration rate \[gfr \] \< 60 milliliter per minute \[ml/min\]/1.73 m\^2).

Keywords: drug therapy
sex differences in relative survival and excess mortality following acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the aim of this study was to estimate the impact of sex on relative survival and excess mortality following acute myocardial infarction (ami) using a population-based cohort within a relative survival framework. patient-level data concerning demographics, co-morbidity, cardiovascular risk factors and treatments at discharge were extracted from the swedish web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (swedeheart), a population-based registry of outcomes for patients hospitalized with acute coronary syndrome. patients were followed-up for their vital status after ami hospitalisation, with censoring at the end of follow-up on the 31st of december, 2013.

details of swedeheart and data validation have been described previously. cases of acute myocardial infarction were defined as stemi and nstemi according to the current european society of cardiology, american college of cardiology and american heart association guidelines and determined at local level by the attending consultant.

Eligibility criteria:
inclusion criteria: * patients were included if they are aged over 18 years who had been hospitalised following acute myocardial infarction between 1st january, 2003 and 31st december, 2013 exclusion criteria: -
pulmonary rehabilitation of patients with a history of covid-19

Conditions: Covid19

Summary: this study will determine the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of covid-19.

in december 2019, a novel coronavirus, sars-cov-2, appeared, causing a wide range of symptoms, mainly respiratory infection. in march 2020, the world health organization (who) declared coronavirus disease 2019 (covid-19) a pandemic. covid-19 has spread rapidly over several months, affecting patients across all age groups and geographic areas. the disease has a diverse course; patients may range from asymptomatic to those with respiratory failure, complicated by acute respiratory distress syndrome. the main objective of this study is to assess the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of covid-19. the patients after covid-19 will be included in the pulmonary rehabilitation protocol. the duration of rehabilitation will depend on the patient's condition: from 7 to 14 days. measurements: * quality of life (whoqol-bref) * body composition (bioelectrical impedance analysis, bc-420 ma, tanita) * weight, height and bmi * spirometry (spirometr pneumo, abcmed) * diffusion lung capacity for carbon monoxide (lungtest 1000) * morphology (crp, d-dimer, wbc) and gasometry (pco2, po2) * chest computed tomography (ct). these parameters will be recorded before the first day of rehabilitation (baseline), after completion of rehabilitation protocol, and three months after completion the rehabilitation protocol. a change in evaluated parameters will be assessed. this will be a prospective, interventional, non-randomized study. all patients will be enrolled by podkarpackie center for lung diseases in rzeszów.

Eligibility criteria:
inclusion criteria: * male and female patients treated in provincial clinical hospital no. 1 in rzeszów/ podkarpackie center for lung diseases in rzeszów, * patients with a history of covid-19, * having obtained written informed consent (signed and dated) to participate in the study, * age at enrollment ≥ 18 years of age, * no contraindications to pulmonary rehabilitation, * no contraindications for body composition testing (bioelectrical impedance analysis). exclusion criteria: * refusal to participate in the study, * patients with any acute disease in the last 3 months before baseline, * patients currently enrolled in any clinical trial, * currently infected patients with covid-19.

Keywords: sars-cov-2 pulmonary rehabilitation quality of life body composition spirometry computed tomography morphology gasometry
natural history study of mngie

Conditions: Mitochondrial Neurogastrointestinal Encephalomyopathy

Summary: non-interventional, prospective, multicenter, natural history study of patients with mitochondrial neurogastrointestinal encephalomyopathy (mngie)


Eligibility criteria:
inclusion criteria: * has mngie exclusion criteria: * substance abuser

Keywords: mngie
medications after adolescent bariatric surgery

Conditions: Pediatric Obesity

Summary: this study will assess the feasibility to assess practicality of early weight loss medication usage in adolescent patients post-vsg with inadequate weight loss. participants who enroll in the study will be prescribed off-label use of weight loss medications for a period of up to 1 year.


Eligibility criteria:
inclusion criteria: * surgical patients in the lpch/stanford bariatric and weight management clinics * inadequate weight loss after vertical sleeve gastrectomy exclusion criteria: * adequate weight loss after surgery; * unwilling to consent or adhere to safety monitoring plan; * any life-threatening or terminal diseases * currently pregnant, breastfeeding, or thinking of becoming pregnant * allergy or medical contraindication to phentermine or topiramate; * history of drug or alcohol abuse; * no known medication interactions; * significant renal or hepatic impairment; * participation in a study of an investigational medication 30 days prior to screening, while the patient is on study, and for 30 days after their last dose of study treatment

Keywords: adolescent bariatric surgery medications weight loss
cognitive function before and after opioid reduction in patients with chronic pain

Conditions: Chronic Nonmalignant Pain; Cognitive Impairment; Opiate Dependence

Summary: this study aims to investigate the cognitive function of patients in the opioid reduction programme at the multidisciplinary pain centre at zealand university hospital køge. the patients will be tested before, halfway through, and after the programme.

the number of patients with chronic non-malignant pain is high and constant. an estimated 3-5% of the population use opioids daily. these patients have a lower quality of life and a higher use of healthcare services. this leads to enormous costs, both human and economic. many patients lose their ability to work, not only because of the pain, but also because of their treatment. for a long period, opioids have been prescribed for chronic pain, even though the evidence is scarce. a rising conscience about opioid use is on the way, and now, there is a tendency to reduce, rather than increase opioids. the reasons are many: constipation, inability to drive, a sense of drowsiness and no relief of pain, just to name a few. furthermore, opioids may have decreased effect over time or may even lead to higher levels of pain. many patients are at first reluctant to start the reduction programme. mostly because the patients may not be aware of the effects, the drugs are having on them. many patients value their opioid treatment as positive and necessary, in spite of the many adverse effects. the investigators wanted to test the cognitive function of patients before, during and after opioid reduction. the results can be used to help patients understand the deleterious effects of high opioid usage, and can also be used to motivate the individual patient along the way.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age and able to provide a written consent * participating in the opioid reduction programme exclusion criteria: * not able to speak and understand danish * patients suffering from dementia or psychosis
spontaneous bacterial peritonitis: incidence, risk factors and outcome

Conditions: Spontaneous Bacterial Peritonitis; Primary Peritonitis; Ascites

Summary: spontaneous bacterial peritonitis (sbp) is a severe complication of ascites in cirrhotic patients. under clinical experience, this condition seems to be more uncommon in finland. the aim of this study was to measure the incidence of sbp in consecutive patients with ascites requiring hospitalization in a finnish university hospital.

spontaneous bacterial peritonitis (sbp) is a complication of liver cirrhosis with high mortality and low survival rates. the incidence of sbp is reported to range from 11-35% in patients with ascites requiring hospitalization. under clinical experience, the incidence of sbp in finland seems to be lower than reported elsewhere. alcohol is the dominant etiologic factor of liver cirrhosis in finland (90%), which might be a factor affecting the incidence of sbp. the aim of this study is to measure the incidence of sbp in finland. we included consecutive patients who underwent diagnostic paracentesis for ascites in tampere university hospital during 2/1994 - 12/1998 and 1/2005 - 3/2007. spontaneous bacterial peritonitis was diagnosed when the ascitic fluid contained over 250 polymorphonuclear cells / mm\^3 regardless of culture and with no evidence of intra-abdominal source of infection e.g. an abscess or a perforation.

Eligibility criteria:
inclusion criteria: * diagnostic paracentesis performed during the study period

Keywords: spontaneous bacterial peritonitis incidence finland etiology liver cirrhosis
study evaluating the long-term safety and efficacy of subcutaneous bapineuzumab

Conditions: Alzheimer Disease

Summary: this study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. the study is open only to subjects who participated in the preceding double-blind study (3133l1-2203 us). subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). one dosage level will be included: 5 mg/week. all subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer disease * completed preceding double-blind study (3133l1-2203 us) * mmse score \> 9. exclusion criteria: * significant brain mri abnormalities * clinically important psychiatric symptoms * history of stroke

Keywords: open-label safety antibody
effect of mediterranean diet on the microbiome of individuals with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes. mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut barrier and that has positive impact in the metabolic control of subjects with type 2 diabetes. this is a 12-week, single-arm clinical study that aims to evaluate if the effect of mediterranean diet in metabolic control of these subjects is mediated by gut microbiota. subjects will receive personalized nutrition counseling where mediterranean diet will be promoted.


Eligibility criteria:
inclusion criteria: * men and women diagnosed with type 2 diabetes mellitus, according to the american diabetes association criteria; * ages 40-80 years; * non-smoker; * willing and able to provide written informed consent. exclusion criteria: * diabetes diagnosed before 40 years old; * changes in oral glycaemic-control medications in the last 3 months; * subjects with hba1c levels under 6.4% or above 10%; * subjects under insulinotherapy; * subjects under corticotherapy; * subjects with triglycerides levels above 4.52 nmol/l (400 mg/dl); * intake of antibiotics in the last 12 weeks; * subjects with a diagnosis of any digestive disease including functional bowel disorders such as ibs.

Keywords: gut microbiota mediterranean diet type 2 diabetes
adaptation and validation of the clinical assessment inventory for eating disorders (cia)

Conditions: Eating Disorders

Summary: the clinical impairment assessment (cia) assesses psychosocial impairment secondary to an eating disorder. the aim of this study was to create and validate a spanish-language version of the cia. using a forward-backward translation methodology, we translated the cia into spanish and evaluated its psychometric characteristics in a clinical sample of 178 ed patients. cronbach's alpha values, confirmatory factor analysis (cfa), and correlations between the cia and the eating attitudes test-12 and the health-related quality of life in ed-short form questionnaires evaluated the reliability, construct validity, and convergent validity, respectively. known-groups validity was also studied comparing the cia according to different groups; responsiveness was assessed by means of effect sizes.


Eligibility criteria:
inclusion criteria: * outpatients were eligible for the study if they had been diagnosed with anorexia nervosa, bulimia nervosa, or an eating disorder not otherwise specified (ednos) by psychiatrists based on criteria established in the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) (american psychiatric association, 1994), and provided written informed consent to participate. exclusion criteria: * patients were excluded if they had a malignant, severe organic disease, could not complete the questionnaires because of language barriers, or did not give written informed consent to participate in the study.
bupivacaine versus liposomal bupivacaine for breast pain management after breast recontruction

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.

this is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy. objectives 1. compare the amount of postoperative narcotic use in patients receiving a bupivacaine or liposomal bupivacaine pectoralis and serratus anterior nerve block. compare these groups to a retrospective control cohort who received local anesthetic infusion but did not receive any nerve block. 2. examine the incidence of narcotic-related side effects in the experimental groups by documenting incidents of nausea and vomiting, time to first ambulation, liquid and solid oral intake. 3. survey patient satisfaction with pain management using a visual analog scale during their hospital stay.

Eligibility criteria:
inclusion criteria: * patients scheduled to have a unilateral, immediate breast reconstruction exclusion criteria: * pregnant * concurrent or recent medical condition that could interfere with study participation including: * hepatitis * alcohol/substance abuse * uncontrolled psychiatric disorders * known allergy * contraindication to amide-type local anesthetics, opioids, or propofol. * body weight of less than 50 kg * participated in another study involving an investigational medication within the prior 30 days * taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.

Keywords: reconstruction bupivacaine liposomal bupivacaine
laser de-epithelialization for epithelial exclusion in root coverage procedure: a clinical study

Conditions: Gingival Recession

Summary: the concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of coronally advanced flap (caf) + subepithelial connective tissue graft (sctg) alone and in combination with laser de-epithelialization in the treatment of gingival recession.

successful treatment of recession defects to obtain new attachment and prevent repair by long junctional epithelium continues to present a serious therapeutic challenge. the concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of coronally advanced flap (caf) + subepithelial connective tissue graft (sctg) alone and in combination with laser de-epithelialization in the treatment of gingival recession. method: in a split-mouth study, 20 patients presenting at least one pair of bilaterally symmetrical miller's class i and class ii buccal gingival recessions will be selected. control site will receive coronally advanced flap with connective tissue graft and test site will receive laser deepithelialization as an adjunct to coronally advanced flap with connective tissue graft. gingival recession depth (grd), gingival recession width (grw), probing depth (pd), clinical attachment level (cal), keratinized tissue width (ktw), plaque index (pi), gingival index (gi), gingival bleeding index (gbi) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment. the root coverage outcomes were also assessed by photogrammetric analysis.

Eligibility criteria:
inclusion criteria:• miller's class i and ii recession defects involving maxillary or mandibular canines or premolars. * similar bilateral recession defects. * systemically healthy patients. * patients willing to participate in study. * age group of 21-57 years. * patients with esthetic concerns. exclusion criteria: * pregnant and lactating woman * patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination. * patients with history of smoking. * teeth with hopeless prognosis. * root surface restoration.
effect of olixia pure® eye drops on tear film thickness in healthy subjects

Conditions: Dry Eye Syndrome; Healthy

Summary: dry eye syndrome (des) is a common ocular disease, especially in the elderly population. despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. however, most of the topical lubricants available are not very well characterized and data about efficacy is sparse. the aim of the present project is to investigate the effect of topically administered olixia pure® eye drops on tear film thickness in healthy subjects. tear film thickness will be determined using ultra high-resolution optical coherence tomography (oct). measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. one eye will receive olixia pure® eye drops, the fellow eye will receive physiologic saline solution as placebo control. the study eye will be chosen randomly.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 6 dpt. * schirmer i test \> 10 mm and but \> 10 sec exclusion criteria: * regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * ametropia =/\> 6 dpt * pregnancy * difference of more than 5 mm in schirmer i test or difference of \> 3 sec in but between the two eyes * known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study

Keywords: tear film thickness optical coherence tomography topical lubricants tear film thickness in healthy subjects